EP2248494B1 - Zusammengesetzte Ophthalmische Mikrokanuele - Google Patents

Zusammengesetzte Ophthalmische Mikrokanuele Download PDF

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Publication number
EP2248494B1
EP2248494B1 EP10168535.2A EP10168535A EP2248494B1 EP 2248494 B1 EP2248494 B1 EP 2248494B1 EP 10168535 A EP10168535 A EP 10168535A EP 2248494 B1 EP2248494 B1 EP 2248494B1
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EP
European Patent Office
Prior art keywords
microcannula
communicating
tip
microns
paragraph
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EP10168535.2A
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English (en)
French (fr)
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EP2248494A1 (de
Inventor
Jeffrey Christian
Stanley R Conston
David J Kupiecki
John Mckenzie
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Iscience Interventional Corp
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Iscience Interventional Corp
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/00781—Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00—Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/0008—Apparatus for testing the eyes; Instruments for examining the eyes provided with illuminating means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M2025/0042—Microcatheters, cannula or the like having outside diameters around 1 mm or less
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids

Definitions

  • the present invention relates to microcannulae that are constructed with multiple components in a composite design.
  • the composite design allows the microcannula to have varying mechanical and delivery properties that will enable ophthalmic treatments by minimally invasive means.
  • a variety of catheters and cannulae are used in ophthalmic surgery to deliver fluid, gas, suction and energy to select regions of the eye.
  • Existing cannulae are typically straight or curved segments of rigid plastic or metal tubing attached to a connector.
  • cannulae that can access and be advanced into very small structures or channels in the eye to perform minimally invasive procedures.
  • Such microcannulae that access curved or tortuous spaces such as Schlemm's Canal or small blood vessels require a combination of flexibility and "pushability", while maintaining a diameter in the range of 50 to 350 microns.
  • the present invention describes microcannulae that are constructed with multiple components in a composite design. The composite design allows the microcannula to have varying mechanical and delivery properties that will enable ophthalmic treatments by minimally invasive means.
  • Patent Number WO2004/093781 Inventor(s): Conston S, Kupiecki D. McKenzle J, Yamamoto R Ophthalmic Microsurgical Instruments
  • the parent application discloses a composite microcannula for access and advancement into a tissue space of the eye comprising at least one flexible, tubular communicating element with an outer diameter of 350 microns or less, with proximal and distal ends, and sized to fit within the tissue space; a proximal connector for introduction of materials, energy and tools; and a reinforcing member in conjunction with the communicating element.
  • the reinforcing element may be formed of metal
  • the microcannula may have a communicating element formed of a flexible polymer and a reinforcing member formed of metal
  • the microcannula may have two or more communicating elements
  • the microcannula may have communicating elements in concentric alignment
  • the microcannula may have communicating elements in parallel alignment
  • the microcannula may comprise two communicating elements where the second communicating element is located within the lumen of the first communicating element
  • the microcannula may have two or more reinforcing elements
  • the microcannula may have a reinforcing element in the form of a coil
  • the microcannula may have a reinforcing element that is tapered toward the distal end of the microcannula
  • the microcannula may have a communicating element formed of a segment of tubing, optical fiber or an electrical conductor
  • the microcannula may be designed to fit within a tissue space such as Schlemm's Canal, an aqueous collector channel, aqueous vein, suprachoroidal space or retinal blood vessel of the eye
  • the microcannula may have a distal tip with a rounded leading edge
  • the microcannula may have a communicating element and a reinforcing element that are joined by an outer sheath
  • the microcannula may have an outer sheath formed of heat shrink tubing
  • the microcannula may have an outer sheath that is thermally fused to the communicating element(s)
  • the microcannula may have a communicating element and a reinforcing element that are joined with an adhesive.
  • the microcannula may have a communicating element and a reinforcing element that are bonded through non-adhesive means such as thermal or ultrasonic welding
  • the parent application further discloses a composite microcannula for access and advancement into a tissue space of the eye comprising at least one flexible, tubular communicating element with an outer diameter of 350 microns or less, with proximal and distal ends, to fit within the tissue space; and a coiled metal reinforcing member attached to the communicating element; wherein the communicating element is formed of a flexible polymer or a superelastic metal alloy.
  • the parent application also discloses a composite microcannula for access and advancement into a tissue space of the eye comprising at least one flexible, tubular communicating element with an outer diameter of 350 microns or less, with proximal and distal ends, and a fluid communicating lumen sized to fit within the tissue space; a proximal connector for introduction of fluid and a second communicating element comprising an optical fiber, where the microcannula provides means for the delivery of both fluid and a visible light signal to the distal tip of the microcannula simultaneously.
  • the parent application further discloses a composite microcannula for access and advancement into a tissue space of the eye comprising at least one flexible, tubular communicating element with an outer diameter of 350 microns or less, with proximal and distal ends, and a fluid communicating lumen sized to fit within the tissue space; a proximal connector for introduction of fluid and a second communicating element comprising an optical fiber, where the microcannula has a rounded distal tip and provides means for the delivery of both fluid and a visible light signal to the distal tip of the microcannula simultaneously
  • the parent application further discloses a composite microcannula for access and advancement into a tissue space of the eye comprising at least one flexible, tubular communicating element with an outer diameter of 350 microns or less, with proximal and distal ends, and a fluid communicating lumen sized to fit within the tissue space; a proximal connector for introduction of fluid, a second communicating element comprising an optical fiber, and a reinforcing member, where the microcannula provides means for the delivery of both fluid and a visible light signal at the distal tip of the microcannula simultaneously
  • the invention comprises a microcannula designed to be advanced into very small tissue spaces during surgery.
  • the microcannula may be used to cannulate Schlemm's Canal, aqueous humor collector channels, aqueous veins, retinal veins and the suprachoroidal space.
  • Such structures range from 50 to 250 microns in diameter, thereby restricting the outer diameter of the microcannula to similar dimensions.
  • the microcannula comprises a flexible elongated element with a connector at the proximal end 3, a distal tip, and a communicating channel 1 therebetween, as seen in Figure 1 .
  • the communicating channel 1 of the microcannula may be used to deliver fluids, materials, energy, gases, suction, surgical tools and implants to a distal surgical site for a variety of surgical tasks.
  • the communicating channel 1 may be the lumen of a tube-like elongated element to transport materials, an optical fiber to transport light energy, or a wire to transport electrical signals.
  • the flexible elongated element with a communicating channel 1 is referred to as the communicating element.
  • a single communicating element may have more than one communicating channel.
  • the microcannula of the present invention incorporates specific design features that enable it to be placed into very small tissue spaces.
  • a key feature is the use of a composite microcannula design that has the appropriate combination of axial stiffness and compliance.
  • the microcannula is desired to be flexible to allow it to be advanced along a curved or tortuous tissue space with minimal tissue trauma, but with sufficient axial stiffness or "pushability" to allow transfer of force to advance the microcannula.
  • the mechanical properties of the microcannula may be tailored by the selection of materials of construction and cross-sectional dimensions.
  • a reinforcing element 2 is attached to the outside of a communicating element.
  • the reinforcing element 2 comprises a material with higher flexural modulus than the communicating element.
  • the communicating element may be a thin wall polymer or metallic tube.
  • the reinforcing element 2 may be formed of any high modulus material such as, but not limited to, metals including stainless steel and nickel titanium alloys, ceramic fibers and high modulus polymers, filled or reinforced polymers, and polymer-polymer composites.
  • the microcannula is desired to be flexible at the distal tip, but transitioning to more rigid mechanical properties toward the proximal end.
  • the transition may comprise one or more steps in mechanical compliance, or a gradient of compliance along the length of the microcannula.
  • the transition in mechanical properties may be accomplished by a change in the cross-sectional area or material properties of the microcannula along its length, the incorporation of one or more stiffening members, or a combination thereof.
  • the microcannula incorporates a communicating element 1 forming the communicating channel 1 fabricated from a flexible polymer with two reinforcing members 4, 5 attached along the length, as seen in Figure 2 .
  • the reinforcing members 5, 5 extends along the communicating element but not completely to the distal tip, while the other reinforcing member 4 extends completely to the distal tip to provide a transition in flexural compliance.
  • the reinforcing members 4, 5 may be formed of a high modulus polymer or metal.
  • a single reinforcing member with a transition in flexural stiffness, such as a tapered wire 2 may be used to reinforce the communicating element.
  • a reinforcing member may be formed of sequential segments of varying modulus or cross-sectional dimensions.
  • the reinforcing elements may be held in place by an outer sheath 6 which may comprise a tight fitting polymer tube or polymer shrink tubing.
  • the reinforcing elements may be adhered or bonded to the communicating element, or may be fully or partially contained within the communicating element.
  • the reinforcing element may also provide kink resistance to the communicating element. This is especially advantageous for use with communicating elements fabricated from high modulus polymers, such as polyimide, polysulfone, ultra-high molecular weight polyethylene and fiber reinforced polymer composites, which kink or deform under high loads, forming a permanent mechanical defect.
  • the reinforcing element may also comprise a malleable material to allow the shape of the microcannula to be adjusted manually to better accommodate a curved shape of the tissue space. Possible malleable materials for the reinforcing element include but are not limited to steel, silver and platinum alloys.
  • the reinforcement of the communicating element may also be accomplished by the incorporation of coil-like members to provide high flexural compliance but also high axial stiffness for pushability, as seen in Figures 3 & 4 .
  • a reinforcing member 7, 8 attached to an outer sheath may be a coiled or wound element on or formed into the exterior surface of the sheath.
  • the reinforcing member 7, 8 may be any suitable high modulus material including metals such as, but not limited to, stainless steel, titanium and superelastic alloys, ceramics such as ceramic fibers, and high modulus polymers or composite polymer structures such as carbon fiber reinforced epoxy.
  • the members may have any suitable cross-section such as round or semi-circular 7 or rectangular 8, as in the case of a flat wire winding.
  • the winding pitch of the reinforcing members may be constant, or it may be varied to achieve differential flexural properties along the length of the microcannula.
  • Multiple wound elements may be incorporated, with the elements being formed of like or different materials.
  • the reinforcing element or multiple reinforcing elements may also be configured to provide a preferred deflection orientation of the microcannula.
  • the composite microcannula of the present invention may also include multiple communicating elements.
  • the microcannula may include two or more elongated communicating elements with a reinforcing member to form a composite structure.
  • the components may be adhered together, placed within an outer sheath, such as heat shrink tubing or an outer communicating element may contain one or more other communicating elements.
  • One of the communicating elements may be used for transport of materials, another for transport of light or energy, thus providing a multifunctional surgical tool.
  • the communicating elements may be aligned side-by-side or arranged around one or more reinforcing elements.
  • one communicating element with an annular cross-section forming a lumen may be fitted with a second communicating element within the lumen.
  • Such concentric alignment of communicating elements may also be used in combination with other communicating elements that are not in concentric alignment.
  • the composite microcannula may be used only to transfer mechanical energy.
  • the microcannula may be used to advance into a tissue space and used to snare a foreign object or area of tissue.
  • the elongated communicating element may be a material such as a wire, polymer, or fiber composite of appropriate mechanical properties.
  • An inner member, which fits and slides within the communicating element, may also be incorporated, the inner member having at least a proximal end and a distal tip. Advancement or withdrawal of the inner member may be used to change the shape of the distal tip of the microcannula, or alternatively to effect a mechanical action at the distal tip.
  • the microcannula also comprises a proximal connecter for the communicating element.
  • the connector may serve to connect a supply of material or energy, such as an infusion syringe or light source to the communicating channel 1 of the communicating element.
  • the microcannula may contain a central section comprising a single or multiple side connectors to allow the attachment of ancillary equipment such as syringes, vacuum or pressure sources, sensing means and the like.
  • the attachment connectors may use standard designs such as Luer fittings or may be designed to only accept connection with specific components.
  • the composite microcannula may incorporate fenestrations or windows along the length.
  • the fenestrations may be used to deliver materials from the sides of the microcannula, for instance the delivery of therapeutic agents to the tissues of Schlemm's Canal.
  • the fenestrations may be used to provide suction against soft tissues.
  • the suction may be used for the removal of tissue or may be used to anchor the microcannula in place while another element is advanced through the microcannula.
  • a composite suction microcannula may be used to strip the juxtacanicular tissues from the inner wall of Schlemm's Canal.
  • the communicating element may be formed of a thin walled polymer or metallic tube of sufficient stiffness to allow it to be advanced into tissues or along a tissue space such as Schlemm's Canal, and of sufficient flexibility to follow the circular tract of Schlemm's Canal. Due to the small size of the target tissue spaces, the microcannula must be appropriately sized. Typically, the microcannula is sized in the range of 50 to 350 microns outer diameter with a wall thickness from 10-100 microns. The cross-section of the microcannula may be round or oval or other bound shape to approximate the shape of a tissue space such as Schlemm's Canal. In some embodiments, a predetermined curvature may be applied to the device during fabrication.
  • Suitable materials for the communicating element include metals, polyetheretherketone (PEEK), polyethylene, polypropylene, polyimide, polyamide, polysulfone, polyether block amide (PEBAX), fluoropolymers or similar materials.
  • the outer sheath may also have surface treatments such as lubricious coatings to assist in tissue penetration and ultrasound or light interactive coatings to aid in location and guidance.
  • the microcannula may also have markings on the exterior for assessment of depth in the tissue space. For example, the markings may take the form of rings around the outer shaft located at regular intervals along the length of the microcannula. The external markings allow user assessment of the length of the tissue space or channel accessed by the microcannula, and the approximate location of the microcannula tip.
  • a first communicating element used for initial placement of the microcannula has a signaling beacon to identify the location of the microcannula distal tip relative to the target tissues, as seen in Figure 5 .
  • the signaling means may comprise an echogenic material for ultrasound guidance, an optically active material for optical guidance or a light source for visual guidance placed at the microcannula tip or placed to indicate the position of the microcannula tip.
  • a plastic optical fiber (POF) 9 is used as a communicating element to provide a bright visual light source at the distal tip 10.
  • the distal tip 10 of the POF 9 is positioned proximal to, near or slightly beyond the distal end of the microcannula sheath and the emitted signal may be detected through tissues visually or using sensing means such as infrared imaging.
  • the POF 9 may also have a tip that is beveled, mirrored or otherwise configured to provide for a directional beacon.
  • the beacon may be illuminated by a laser, laser diode, light-emitting diode, or an incandescent source such as a mercury halogen lamp.
  • the signaling means may comprise visualization aids along the length of the microcannula, for example a side emitting optical fiber of discrete length leading up to the distal end or at a known point along the microcannula may be used to indicate the position of the microcannula and the distal tip.
  • the beacon assembly 11 and POF 9 may be removed.
  • the connection point may be sealed with a cap or with a self-sealing mechanism such as a one-way valve or an elastomer seal.
  • the POF may be placed co-linear to or within the lumen of a delivery communicating channel, allowing for delivery of fluids or gases through the delivery communicating channel without requiring removal of the beacon assembly.
  • the microcannula may use other imaging technologies to locate the signal beacon.
  • Other possible imaging technologies include but are not limited to magnetic resonance imaging, fluoroscopy and ultrasound.
  • the beacon signal may take other forms to match the imaging technology such as a radiopaque marker attached to or embedded at or near the distal tip of the microcannula.
  • an echogenic material or coating may be added to the distal tip, etc.
  • the microcannula has a rounded distal tip 12 to minimize tissue trauma and aid the ability of the microcannula to be advanced into small tissue spaces, as seen in Figures 6 and 7 .
  • the rounded tip 12 may be the same outer diameter as the microcannula or larger, depending on the specific properties desired.
  • the rounded tip 12 may be formed and attached to the microcannula during assembly or alternatively, the microcannula tip may be processed by a secondary operation to form a rounded contour.
  • the rounded tip 12 is used in conjunction with a light emitting signaling beacon 9 such that the light is delivered proximal to the rounded tip, and the tip acts to disperse the light 13.
  • the dispersed light aids visualization when viewing the microcannula off axis, for example when advancing the microcannula in Schlemm's Canal.
  • Another feature of the invention is the use of a communicating element to deliver fluid to the distal tip during advancement of the microcannula within the tissue space.
  • the injection of small amounts of fluid may serve to open the tissue space ahead of the microcannula tip and lubricate the channel to greatly increase the ability to advance the microcannula atraumatically.
  • Delivery of surgical viscoelastic materials such as hyaluronic acid solutions and gels are especially efficacious in aiding advancement and placement of the microcannula. Delivery of fluids, especially gel-like viscoelastic materials, allows for the dilation of the tissue space in the circumstance that a constriction or partial blockage is reached during advancement of the microcannula.
  • a particularly effective embodiment comprises a microcannula with a communicating element such as an optical fiber to provide a signaling beacon at the microcannula tip and a second communicating element to deliver a fluid such as a solution of hyaluronic acid to the microcannula tip while the signaling beacon is active.
  • a microcannula may be manually manipulated and used to deliver fluids to aid microcannula advancement while simultaneously observing the microcannula tip location along the tissue space.
  • the combination of fluid delivery in the path of the microcannula and the observation of the microcannula tip when advanced, retracted and torsioned allows precisely controlled manipulation and advancement in tight tissue spaces. The ease of manipulation is further aided with the addition of a reinforcing member to the communicating element of the microcannula.
  • a communicating element with a lumen (Polyimide Tubing 0 003 inch ID (76 microns) x 0.004 (102 microns) inch OD), a second communicating element comprising a plastic optical fiber 85-100 microns, (0 0034-0.0039 inch OD), a reinforcement element (304SS wire ground to 0.001 inches (25 microns) in the distal 2 5 inches (63 5mm) tapering up over a 1 0 inch length (25 4mm) to a diameter of 0 003 inches (76 microns) for the remaining length of the microcannula), and an outer sheath comprising polyethylene teraphthalate (PET) shrink tubing (0.008 inch (203 microns) ID and 0 00025 (6 microns) inch wall thickness), were all cut to lengths appropriate for setting the final overall length of the microcannula The distal ends of the inner components were then aligned flush and joined with an
  • the reinforcing element was tapered and aligned to provide more flexibility distally and stiffer reinforcement more proximal In the microcannula
  • the three elements were aligned in a triangular pattern rather than an in-line pattern to create an assembled profile with the smallest major-axis dimension.
  • the assembly of multiple components was then inserted Into the heat shrink tubing outer sheath so that the inner elements were aligned for capture in the heat shrink tubing At the proximal end of the microcannula assembly, the two communicating elements were extended outside of the heat shrink tubing and separated
  • the assembly was placed in a hot air stream at 220-240 degrees F (104-116 degrees C), so the heat shrink recovered and the inner elements were captured to form a multi-component shaft of the microcannula
  • the composite microcannula demonstrated a final outer dimension of 200 to 230 microns with a lumen of 75 microns
  • extension communicating elements were bonded to the proximal end of the two communicating elements respectively
  • the extensions were finished by adding a Luer infusion connector and an optical connector to serve as interfaces to the communicating elements Testing of the completed microcannula was performed, demonstrating simultaneous fluid delivery from the Luer connector and light delivery from the optical connector to the microcannula tip.
  • the microcannula fabricated in Example 1 was tested in accessing Schlemm's Canal of an enucleated human eye
  • the first communicating element, the infusion lumen was attached to a syringe filled with fluid at the proximal Luer connection
  • the second communicating element, the optical fiber was attached to a light emitting source at the proximal connection
  • two radial incisions were made to a depth of Schlemm's Canal and extending from the clear cornea approximately 3 mm posterior
  • a third incision was made across the posterior end of the radial incisions to define a surgical flap
  • the flap was then excised up toward the limbus, exposing Schlemm's Canal
  • the distal tip of the composite microcannula was inserted into Schlemm's Canal
  • the light source for the second communicating element was activated and the microcannula was advanced along Schlemm's Canal
  • the light emitting from the microcannula tip was seen through the sclera and used to help guide the
  • the microcannula was advanced along Schlemm's Canal until the tip was seen reaching an appropriate location.
  • the syringe connected to the first communicating element extension was used to inject fluid (Healon GV, Advanced Medical Optics, Inc) into Schlemm's Canal as needed to aid microcannula advancement.
  • fluid Healon GV, Advanced Medical Optics, Inc
  • the microcannula was repositioned for additional fluid injections and subsequently completely retracted from Schlemm's Canal
  • an atraumatic rounded distal tip component was fabricated for placement over a composite microcannula Polyethylene teraphthalate (PET) shrink tubing (Advanced Polymers, Nashua NH) 0 008 inch (203 microns) ID and 0 00025 inch (6 microns) wall thickness was obtained
  • PET Polyethylene teraphthalate
  • a length of shrink tubing approximately 2 cm long was placed over a mandrel comprised of a section of hypodermic tubing 0 003 inch (76 microns) x 0 007 (178 microns) inch diameter Teflon coated steel wire, 0 0025 inch (64 microns) diameter was held inside the hypodermic tubing and extending beyond the end of the shrink tubing
  • a point heat source adjusted soldering iron set to 500 degrees C was brought into close proximity to the end of the heat shrink tubing The heat was allowed to melt the end of the tube without touching the heat source to the polymer.
  • the surface tension of the polymer melt created a rounded "ball-end" tip with a 0 0025 inch (64 microns) diameter lumen
  • the polymer was allowed to cool and then stripped off of the mandrel and wire.
  • the length of PET shrink tubing held beyond the end of the mandrel determined the final diameter of the rounded tip Approximately 0 08 inches (2 mm) of extension yielded tips approximately 0 008 inch or 200 micron outer diameter
  • the finished component was then drawn over the distal end of a composite microcannula similar to Example 1, which was 0.0075 inches or 190 microns in largest diameter
  • the tip component was butted up to the end of the composite elements and then shrunk in place with a hot air stream at 240 degrees F (160 degrees C) to attach the tip.
  • the body of a composite microcannula was formed out of a wire coil and polymer heat shrink tubing.
  • the coil was fabricated by progressively winding a 0 003 inch (76 microns) by 0.001 inch (25 microns) stainless steel ribbon under 20 grams tension around a 0 0055 inch (140 microns) diameter stainless steel mandrel.
  • the resulting wire ribbon coil had an outside diameter of 0 008 inches or 200 microns, an inside diameter of 0 006 inches or 150 microns, and overall length of approximately 5 inches (127 mm)
  • a 6 inches (152 mm) long piece of 0 010 inch or 250 micron ID PET heat shrink with a preformed rounded tip at one end was slipped over the coil and recovered using hot air over the entire length of the coil
  • a 0 004 inch (102 microns) diameter optical fiber was then loaded into the lumen of the microcannula and advanced to the distal end The proximal ends were terminated into a fluid infusion lumen and 0 5mm diameter optical fiber respectively
  • the distal portion of the assembly was found to have desirable mechanical characteristics of flexibility and resistance to kinking
  • a composite microcannula with several communicating elements in parallel alignment forming a distal segment with a maximum outer diameter of 250 microns was fabricated.
  • the outer member comprised a tubular structure and the two internal communicating elements comprised elongated linear elements At the distal end of the outer structure, an atraumatic spherical-shaped distal tip was formed.
  • a communicating lumen was formed in the annular space between the outer tube and the inner members
  • the inner members comprised an optical fiber and a reinforcement element.
  • the outer member was a tubular structure comprised of three sizes of PEBAX (polyamide/polyether copolymer), 63 durometer tubing:
  • the outer tubular element was constructed by first cutting the individual shaft segments to lengths appropriate for setting the final overall length of the microcannula.
  • the mid section was inserted into the proximal section with appropriate length for an overlapping bond.
  • the tubular elements were then bonded together with an adhesive or by melt-fusing the polymeric tubes together with a controlled heat process
  • the distal section was bonded to the mid shaft similarly. These tubes were bonded together to form a decreasing outer diameter toward the distal tip
  • the reinforcement element comprised 304 Stainless Steel wire size 0.0010 +/-0 0005 inch (25 +1- 13 microns) OD
  • the optical fiber comprised a elastic optical fiber fabricated from polystyrene and polymethylmethacrylate with an 85 to 100 micron OD.
  • the reinforcement element and the optical fiber were cut to lengths appropriate for setting the final overall length of the microcannula.
  • the reinforcement element and optical fiber were inserted into the outer member assembly
  • the inner elements were aligned with the distal tip of the distal shaft
  • An atraumatic rounded tip was formed at the end of the distal section A quick drying UV curable adhesive (loctite Brand 4305) was applied to the outer section of the distal tip An adhesive of medium to high viscosity was chosen so that the adhesive application formed a bulbous structure approximately 0 001 inch (25 microns) thickness. A small, approximately 0 03 microliter amount of adhesive was used to create the tip The adhesive was cured to form the spherically shaped atraumatic tip with a diameter of 0 010 inches or 250 microns
  • the free end of the infusion lumen was terminated with a female Luer port
  • the proximal end of the optical fiber was connected to a Plastic Optical Fiber (POF) that terminated in an optical SMA connector
  • the area of the microcannula assembly where the optical fiber and reinforcement enter the inside of the outer member was sheathed in a protective plastic housing forming a hub
  • the hub also provided a means for manipulation of the microcannula
  • the optical SMA termination was connected to a light source and light was conducted to the tip of the microcannula to provide a signal beacon.
  • the Luer termination was connected to a fluid-filled syringe and activation of the syringe resulted in fluid delivery through the microcannula exiting from the distal tip Delivery of the signal beacon light and fluid could be activated individual or simultaneously.
  • Example 6 a composite microcannula with several communicating elements in parallel alignment forming a distal segment with a maximum outer diameter of 350 microns was fabricated similarly to Example 6
  • the outer member was constructed with three sizes of PEBAX tubing with slightly larger dimensions:
  • a spherically shaped atraumatic tip was fabricated on the microcannula by the method described in Example 6, forming a distal tip with a diameter of 0.014 inches or 350 microns.
  • no reinforcing element was placed into this cannula construction, however a plastic optical fiber was incorporated similar to Example 6.
  • the optical SMA termination was connected to a light source and light was conducted to the tip of the microcannula.
  • the Luer termination was connected to a fluid-filled syringe and activation of the syringe resulted in fluid delivery through the microcannula exiting from the distal tip.
  • Example 6 and Example 7 were tested in human eyes similarly to the method of Example 2.
  • the distal tip and distal segments of the microcannulae could be advanced along the entire circumference of Schlemm's Canal for 360 degrees while observing the beacon signal at the microcannula tip through the sclera.
  • Injection of small amounts of hyaluronic acid-based surgical viscoelastic fluid (Healon GV, Advanced Medical Optics Inc.) delivered during advancement of the microcannulae decreased the force required for advancement and provided for more progressive advancement.
  • Healon GV Advanced Medical Optics Inc.
  • a composite microcannula with several collinear elements was fabricated similar to Example 6.
  • the outer structure had no mid section in that the proximal section was connected directly to the distal section.
  • a family of microcannulae were fabricated with the same outer dimensions and material characteristics but with varying flexural rigidity.
  • Flexural rigidity of a body is equal to the product of the flexural modulus, E, and the moment of inertia of the cross-section, I, and is typically called EI.
  • the outer sheath comprised PEBAX tubing with 0.008 inch (200 micron) OD and 0.006 inch (150 micron) ID.
  • the sample set comprised the tubing alone without reinforcing element(s), the tubing with a 100 micron outer diameter plastic optical fiber placed within the lumen and the tubing with stainless steel reinforcing wires of varying size in the lumen.
  • the ends of the components were secured with adhesive, while forming an atraumatic spherically shaped tip, as described in Example 6.
  • the lumen allowed fluid delivery to the tip of the microcannula from a proximally attached Luer connector.
  • microcannulae The flexural rigidity of the microcannulae were evaluated by mechanical testing
  • the microcannulae cantilever force-displacement characteristics were tested on a mechanical testing apparatus with a high sensitivity load cell (Instron model 5542, 5N Load Cell).
  • Example 10 The microcannulae fabricated in Example 10 were tested for the ability to access Schlemm's Canal of a human eye similar to the methods described in Example 2.
  • the distal tip of the microcannulae were inserted into the Canal and advanced without delivery of fluid from the microcannula tip The number of degrees of advancement around the eye was recorded for each microcannula
  • the test was repeated with the delivery of a small amount of viscoelastic fluid (Healon GV, Advanced Medical Optics Inc) from the microcannula tip during advancement
  • Healon GV a hyaluronic acid based viscoelastic fluid
  • the microcannulae with low flexural rigidity When tested for the degree of advancement within Schlemm's Canal, the microcannulae with low flexural rigidity could be slowly advanced along Canal until further advancement was no longer possible due to lack of force transfer. These lower flexural rigidity devices tended to bend or kink when reaching the limit of travel The microcannulae with very high flexural rigidity could be advanced a short distance until further advancement was no longer possible due to the inability of the microcannula to bend with the curve of Schlemm's Canal if advanced further, the microcannula with very high flexural rigidity in some cases punctured through the outer wall of the Canal, an undesirable result
  • the testing was performed by advancing each device manually, attempting to use a comparable maximum force for each test run, so as to maintain an adequate comparison In cases where the cannula did not traverse the full extent of the Canal, the force required to advance the cannula increased with increased extent of cannulation, which was attributed to interaction of the compliance properties

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Claims (4)

  1. Zusammengesetzte MikrokanĆ¼le zur KanĆ¼lierung des Schlemm-Kanals eines Auges, umfassend:
    ein biegsames lƤngliches Element mit einem VerbindungsstĆ¼ck am proximalen Ende (3), einer distalen Spitze (12) und einem Kommunikationskanal (1) dazwischen und mit einem AuƟendurchmesser von nicht mehr 350 Mikrometer,
    wobei der Kommunikationskanal eine Lichtleitfaser ist, um Lichtenergie zu transportieren,
    wobei das VerbindungsstĆ¼ck zum Anschluss an eine Lichtquelle dient und um eine sichtbare Lichtquelle (13) an der distalen Spitze (12) bereitzustellen, und
    wobei die distale Spitze abgerundet ist,
    dadurch gekennzeichnet, dass die zusammengesetzte MikrokanĆ¼le eine Biegesteifigkeit im Bereich von 3,09 E-11 bis 2,86E-10 kN*m2 aufweist.
  2. MikrokanĆ¼le nach Anspruch 1, wobei die abgerundete Spitze, wenn der abgerundeten Spitze Licht zugefĆ¼hrt wird, bewirkt, dass Licht (13) zur besseren auƟermittigen Visualisierung gestreut wird.
  3. MikrokanĆ¼le nach einem der vorhergehenden AnsprĆ¼che, ferner umfassend einen gleitfƤhigen AuƟenbelag.
  4. MikrokanĆ¼le nach Anspruch 1, wobei das biegsame lƤngliche Element in einem Polymerschlauch (6) enthalten ist.
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US8348924B2 (en) 2013-01-08
US20050171507A1 (en) 2005-08-04
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